Frequently Asked Questions

What is X-Repair made of?
X-Repair is a woven mesh of poly-L-lactic acid.

Is it degradable?
Yes, once it is used in surgery, it will slowly degrade in the body over the next 12 - 24 months, maintaining approximately 90% of its strength at 12 months. This slow rate of degradation allows the biological repair to occur while X-Repair augments the stability of the repair site. Since X-Repair degrades in the body, it is not necessary for it to be removed surgically.

How does X-Repair augment (or assist) the surgical repair?
X-Repair is specifically designed to have mechanical properties similar to human tendon. It also has high suture retention strength. These two features allow X-Repair to be sutured in place, and assists the surgically repaired tendon by functionally sharing the load that the tendon bears when the tendon is used.

How often does rotator cuff surgery fail?
The literature indicates that when an imaging system (MRI or ultrasound) is used to assess the surgical outcome, the success rate is dependent, at least in part, on the size of the rotator cuff tear. Small to medium tears fail 26% of the time, large tears fail 48% of the time, and massive tears fail 60% of the time. There is a large range of reported success rates, and so the actual success rate of an individual surgeon is likely to be different than these reported rates.

What types of rotator cuff repairs are at highest risk of failure?
While there is always some risk of an unsuccessful surgical procedure, the greatest success rates occur when the rotator cuff tears are small. There is higher risk of failure when the:

  • Rotator cuff tear is clinically regarded as large or massive
  • Surgical repair is of a previously torn tendon
  • Patient has some underlying condition that may compromise the biologic repair

Can X-Repair be used in arthroscopic surgery?
Yes, it can be used in arthroscopic surgery or in open surgery. In fact, the majority of surgeries performed with X-Repair have been done arthroscopically.

What makes X-Repair different from other products used for augmentation of tendon repair?
X-Repair has a number of important features other products do not have. For example, X-Repair is stiffer and stronger than the other products, with mechanical properties equivalent to human tendon. It has high suture retention strength, allowing those properties to be imposed when X-Repair is implanted. X-Repair has a very slow degradation rate, allowing biologic repair to occur before the mechanical properties decrease. Most products are allogeneic (from human cadavers) or xenogeneic (from animals), potentially increasing risk of infection, and having a larger variability in the product properties.

Can X-Repair be cut to size?
No, Since X-Repair is a woven material, it should not be cut during surgery. It is available in a broad range of sizes to meet almost all surgical needs.

Can X-Repair be used on tendons other than rotator cuff?
Yes, X-Repair is cleared by the FDA for repair of tendons including rotator cuff, patellar, Achilles, biceps, and quadriceps tendons. X-Repair is also cleared for reinforcement of soft tissues that are repaired by suture or suture anchors.

How do I know if X-Repair is right for me ?
Patients - Click here

How can I find out more information about X-Repair or contact Synthasome?
Please feel free to contact us and we would be happy to answer your questions or provide any additional information.